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BioWorld - Saturday, November 30, 2024
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» FDA retains right to observe accredited body evaluations in final guidance for ASCA pilot
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FDA retains right to observe accredited body evaluations in final guidance for ASCA pilot
Sep. 24, 2020
By
Mark McCarty
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The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is intended to foster med-tech regulatory harmonization, but stakeholders saw a number of issues with the September 2019 ASCA draft guidance.
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